Methodology and application of process analytical technology (PAT) for traditional Chinese medicine manufacturing:a review / 中国中药杂志

Owing to the advancement in pharmaceutical technology, traditional Chinese medicine industry has seen rapid development. Preferring conventional manufacturing mode, pharmaceutical enterprises of traditional Chinese medicine have no effective process detection tools and process control methods. As a result, the quality of the final products mainly depends on testing and the quality is inconsistent in the same batch. Process analytical technology(PAT) for traditional Chinese medicine manufacturing, as one of the key advanced manufacturing techniques, can break through the bottleneck in quality control of medicine manufacturing, thus improving the production efficiency and product quality and reducing the material and energy consumption. It is applicable to the process control and real-time release of advanced manufacturing modes such as intelligent manufacturing and continuous manufacturing. This paper summarized the general idea of PAT for traditional Chinese medicine manufacturing. Through the analysis of the characteristics and status quo of the technology, we summed up the methodology for the continuous application and improvement of PAT during the whole life-cycle of traditional Chinese medicine. The five key procedures(process understanding, process detection, process modeling, process control, and continuous improvement) were summarized, and the application was reviewed. Finally, we proposed suggestions for the technical and regulatory challenges in implementing PAT in traditional Chinese medicine industry. This paper aims to provide a reference for development and application of PAT in advanced manufacturing, intelligent manufacturing, and continuous manufacturing of traditional Chinese medicine industry.

Research progress and maturity assessment of continuous manufacturing of traditional Chinese medicine / 中国中药杂志

The pharmaceutical manufacturing model is gradually changing from intermittent manufacturing to continuous manufacturing and intelligent manufacturing. This paper briefly reviewed the supervision and research progress in continuous pharmaceutical manufacturing in China and abroad and described the definition and advantages of continuous pharmaceutical manufacturing. The continuous manufacturing of traditional Chinese medicine(TCM) at the current stage was summarized in the following three terms: the enhancement of the continuity of intermittent manufacturing operations, the integration of continuous equipment to improve physical continuity between units, and the application of advanced process control strategies to improve process continuity. To achieve continuous manufacturing of TCM, the corresponding key technologies, such as material property characterization, process modeling and simulation, process analysis technology, and system integration, were analyzed from the process and equipment, respectively. It was proposed that the continuous manufacturing equipment system should have the characteristics of high speed, high response, and high reliability, "three high(H~3)" for short. Considering the characteristics and current situation of TCM manufacturing, based on the two dimensions of product quality control and production efficiency, a maturity assessment model for continuous manufacturing of TCM, consisting of operation continuity, equipment continuity, process continuity, and quality control continuity, was proposed to provide references for the application of continuous manufacturing technology for TCM. The implementation of continuous manufacturing or the application of key continuous manufacturing technologies in TCM can help to systematically integrate advanced pharmaceutical technology elements and promote the uniformity of TCM quality and the improvement of production efficiency.

Educação permanente em saúde para elaboração de um fluxograma de atendimento a pacientes cirúrgicos eletivos / Permanent education in health to elaborate a flowchart of care for elective surgical patients

A assistência ao paciente cirúrgico é considerada complexa pelas características inerentes ao próprio ambiente, o que demanda dos profissionais um perfil altamente especializado considerado um determinante para a garantia de uma assistência contínua e individualizada. Nesse sentido, é inegável a importância do papel do enfermeiro na realização do planejamento e gerenciamento do cuidado aos pacientes cirúrgicos, uma vez que é esse profissional que participa de todas as etapas do cuidado prestado. O objetivo foi desenvolver um fluxograma de atendimento aos pacientes cirúrgicos eletivos utilizando como estratégia a educação permanente em saúde. Estudo qualitativo, do tipo pesquisa-ação, contemplando as etapas exploratória, de planejamento e de ação. A coleta de dados ocorreu nos meses de outubro a novembro de 2022, por meio de entrevista semiestruturada e encontros coletivos. Os dados coletados, transcritos e validados pelos participantes, foram analisados pelo método de análise de conteúdo de Bardin (2004), com apoio do software Nvivo®. Foram identificadas quatro categorias que, articuladas entre si, originaram a metacategoria: Mapeamento do processo cirúrgico eletivo: desafios e perspectivas para o gerenciamento do cuidado de enfermagem. Constatou-se que: o mapeamento das etapas de assistência cirúrgica é o ponto de partida para compreender os desafios vivenciados por enfermeiros no gerenciamento do cuidado e seu impacto na assistência cirúrgica eletiva, e que a dificuldade de acesso às consultas especializadas, a terceirização dos serviços a falta de gerenciamento da demanda espontânea e programada, representam pontos críticos na gestão da fila. O perfil profissional somado à sobrecarga foram considerados importantes e decisivos na otimização e resolutividade do processo. Notou-se também que, os enfermeiros reconhecem as ações que envolvem o gerenciamento do cuidado e entendem sua importância para efetivação da assistência qualificada. Conclui-se que, a ressignificação do contexto investigado, por meio da educação permanente em saúde, possibilitou a construção e desconstrução saberes e práticas voltados a linha de cuidado cirúrgico, valorizou o protagonismo dos participantes, e possibilitou o desenvolvimento de ações de melhorias na construção do fluxograma de atendimento

Surgical patient care is considered complex due to the inherent characteristics of the environment itself, and this complexity demands a highly specialized profile from professionals, which is considered a determinant for ensuring continuous and individualized care. In this sense, the importance of the nurse's role in carrying out the planning and management of care for surgical patients is undeniable, since it is this professional who participates in all stages of the care provided. The objective was to develop a flowchart of care for elective surgical patients using permanent health education as a strategy. Qualitative study, of the action-research type, contemplating the exploratory, planning and action stages. Data collection took place from October to November 2022, through semi-structured interviews and collective meetings. The collected data, transcribed and validated by the participants, were entered into the Nvivo® software and analyzed using Bardin's (2004) content analysis method. Four categories were identified that articulated with each other, originating the metacategory: Mapping of the elective surgical process: challenges and perspectives for the management of nursing care. It was found that: mapping the stages of surgical care is the starting point for understanding the challenges experienced by nurses in care management and their impact on elective surgical care, and that the difficulty in accessing specialized consultations, the outsourcing of services the lack of management of spontaneous and scheduled demand represent critical points in queue management. The professional profile added to the overload were considered important and decisive in the optimization and resolution of the process. It was also noted that the nurses recognize the actions that involve the management of care and understand its importance for the effectiveness of qualified assistance. It is concluded that the re-signification of the investigated context, through permanent health education, enabled the construction and deconstruction of knowledge and practices aimed at the line of surgical care, valued the protagonism of the participants, and enabled the development of improvement actions in the construction of the service flowchart